Regulatory Publishing Roles

Virtual Calibre MSC Sdn Bhd

Kuala Lumpur

2-10 Years

MYR 3,000 - 15,000 per month

This job is no longer accepting applications

Posted 2 months ago

Job Description

Join a global pharmaceutical services company expanding its Regulatory Affairs team in Malaysia. We're looking for Mandarin-speaking talents to support regulatory publishing and submission activities across multiple levels.

Open Positions:

Regulatory Associate Trainee Entry-level, fresh grads welcome
Regulatory Associate 12 years experience in regulatory or publishing
Senior Regulatory Associate 3+ years experience, strong publishing skills
Team Lead Regulatory Publishing Leadership role, 5+ years experience

Key Responsibilities:

Prepare, format, and publish regulatory documents (eCTD, NeeS, paper submissions)
Ensure compliance with global regulatory standards and timelines
Collaborate with cross-functional teams (Regulatory, QA, Clinical, etc.)
Use publishing tools like Lorenz DocuBridge, Extedo eCTDmanager, or similar
Support submission lifecycle from planning to delivery

Requirements:

Mandarin fluency is mandatory (spoken & written)
Degree in Life Sciences, Pharmacy, or related field
Detail-oriented with strong documentation and formatting skills
Familiarity with regulatory guidelines (ICH, FDA, EMA, CFDA, etc.)
Experience with publishing tools is a plus (training provided for Trainee level)

Spotlight

Health insurance

Education

Bachelors/ Degree

More Info

Job Type:

Permanent Job

Industry:

Life Science

Role:

Regulatory Affairs Executive

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Malaysian

About Company

Virtual Calibre MSC Sdn Bhd

Virtual Calibre Group is a JAST Company (Japan System Techniques Ltd) which is listed in Tokyo Stock Exchange Board 1 with its operationâ€™s spreading across Japan, China, Thailand and Singapore with revenue exceeding RM 850 Million in FY 2018.

With the acquisition, Virtual Calibre will be expanding its SAP Consulting Services in the ASEAN region as one of global delivery centers, supporting Malaysian and other ASEAN Clients. We provide services across various industry sectors. Our offshore delivery approach is flexible and is customized to the specific needs
of our clients. We are one of the fastest growing SAP provider in the region.

These key competitive advantages are the core foundation on which our SAP Consulting practice is built upon

OUTREACH: We have delivered SAP projects both locally and in the ASEAN regions as well as the Middle East.
FOCUS: We are specialists in key SAP Solution such as SAP S/4 Hana and SAP ECC 6.0
VALUE: We place high priority on customer relationships, trust and integrity
EXPOSURE: We have over 19 years of SAP industry experience
COST: We are confident that we offer among the most competitive rates in the market
TALENT: We have an excellent lineup of SAP Consultants locally as well as access to an extensive pool of SAP resources all over the world.

Our Services in SAP S/4 Hana and SAP ECC 6.0 are:

- Implementation
- Production Support
- Remote Consulting
- Talents

Please visit our website for more information: www.virtualcalibre.com